MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD RT SZ 1-2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74025716

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Inflammation (1932); Pain (1994); Arthralgia (2355); Inadequate Pain Relief (2388); Joint Laxity (4526); Unequal Limb Length (4534); Implant Pain (4561); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that, after a second tka surgery had been performed in 2017, the patient experienced a lot of pain.It is unknown if this adverse event has been solved.Current health status of patient is unknown.

Manufacturer Narrative

Section h3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported adverse events could not be determined.The reported car accidents should not be ruled out as contributory factors.While this case documents that the patient is super sensitive and highly allergic to many foods and medicines; it is unknown if the patient has an undiagnosed sensitivity or allergy to one or more of the implanted biomaterials.The patient reports that surgeon wants ¿to replace my left knee and work on the right knee;¿ the swelling and pain experienced by the patient remains on going.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Also, warnings and precautions states that the patient should be warned of surgical risks, and made aware of possible adverse effects.The patient should be warned that the implant can become damaged as a result of strenuous activity or trauma.Besides, possible adverse effects section states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Based on the information provided, the unsatisfactory experience could be confirmed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.H6: health effect: clinical code and health effect: impact code.

Event Description

It was reported that, after a tka revision surgery had been performed in (b)(6) 2017, the patient experienced a lot of pain and swelling.Pain had been treated with physical therapy and medication, but with no effect.The pain condition of the patient remains on going.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that all documents presented as of this date have been reviewed and considered and unless indicated, do not contribute to the clinical investigation.Based on the information provided, the patient was revised due to the reported pain, swelling, and instability.The patient's age, history of severe osteoarthritis, the sedative effect of the percocet and the patient reported 4 or more car accidents could not be excluded as contributing factors.It is unknown if the instructions for use for the knee system was adhered to.Therefore, the definitive clinical root cause of the reported pain, swelling, and instability could not be determined but the laxity in the knee prior to the revision could account for the instability and pain but the root cause is not known.While this case documents that the patient is super sensitive and highly allergic to many foods and medicines; it is unknown if the patient has an undiagnosed sensitivity or allergy to one or more of the implanted biomaterials.The patient reports that surgeon wants ¿to replace my left knee and work on the right knee.¿ the patient impact beyond the reported pain, swelling, and instability could not be determined since the patient¿s symptoms have not been reported following the revision and improved joint stability.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Also, warnings and precautions states that the patient should be warned of surgical risks, and made aware of possible adverse effects.The patient should be warned that the implant can become damaged as a result of strenuous activity or trauma.Besides, possible adverse effects section states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Based on the information provided, the unsatisfactory experience could be confirmed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Event Description

It was reported that, after a right tka revision surgery had been performed on (b)(6) 2017 in which the insert was replaced with a new journey ii insert xlpe deep dished right size 1-2 15mm, the patient experienced a lot of pain and swelling.These conditions have been treated with physical therapy, morphine pills, and cortisone injections without success.Outcome remains ongoing.

• Brand Name: JRNY II ISRT XLPE DD RT SZ 1-2 15MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18634983
• MDR Text Key: 334462293
• Report Number: 1020279-2024-00269
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556096666
• UDI-Public: 00885556096666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2024
• Device Catalogue Number: 74025716
• Device Lot Number: 14BM15619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 03/06/2024; 04/05/2024
• Supplement Dates FDA Received: 02/08/2024; 03/11/2024; 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PT, RFLA, MORPHINE PILLS, CORTISONE INJECTION
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 81 KG